A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

Healthy Clinical Trial

Official title:

A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951873
• Other study ID #: NN7129-3754
• Secondary ID: 2009-011267-37
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2009
• Last updated: May 12, 2016
• Start date: July 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Caucasian origin

• Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive

• Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion Criteria:

• Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)

• Previous participation in this trial, defined as randomised to receive trial product

• Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator

• Known history of atherosclerosis or thromboembolic events

• Overt bleeding, including from gastrointestinal tract

• Hepatitis B or C infection

• HIV infection

• Positive test for drugs of abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Healthy
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• activated recombinant human factor VII, long acting
Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
• placebo
Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
• activated recombinant human factor VII, long acting
Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		assessed throughout the trial period from visit 1 to visit 5	Yes
Secondary	Area under activity concentration-time curve from time zero to infinity		assessed up to 168 hours after trial product administration	No

External Links

•   Clinical Trials at Novo Nordisk